|Design of Dose Response Clinical Trials
Naitee Ting, Boehringer-Ingelheim Pharmaceuticals Inc.
Monday, April 5, 2012
4:00 p.m., room 223, Weber Bldg
In the process of drug discovery and drug development, understanding the dose-response relationship is one of the most challenging tasks. It is also critical to identify the right range of doses in early stages of clinical development so that Phase III trials can be designed to confirm these doses. Usually at the beginning of Phase II, there is not a lot of available information to help guiding the study design. At this stage, Phase II clinical studies are needed to establish proof of concept (PoC), to identify a set of potentially effective and safe doses, and to estimate dose-response relationships.